Subcommittee Finds Significant Problems with Administration’s Handling of Serology Testing

Apr 24, 2020
Press Release
FDA Does Not Know Whether Tests Currently on the Market Work

Washington, D.C. (Apr. 24, 2020)—Today, Rep. Raja Krishnamoorthi, the Chairman of the Subcommittee on Economic and Consumer Policy, released a new staff memo with preliminary findings showing wide gaps in the Trump Administration’s handling of serological testing based on a briefing with senior officials from the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Department of Health and Human Services (HHS).

 

Chairman Krishnamoorthi issued the following statement in conjunction with the memo:

 

“Serology testing for coronavirus has the potential to be a critical tool going forward for our nation.  Unfortunately, senior FDA and CDC officials admitted that they have not put Americans in the best position to use this tool.  I was shocked to learn that we do not have the ability to know whether the available serology tests work and the FDA has no plans to make that a reality. 

“The Subcommittee appreciates the immense challenges facing HHS, FDA, CDC, and other health agencies in the midst of the coronavirus pandemic.  But when it comes to serological testing, more should be done to help protect the American people from suspect companies seeking to take advantage of the crisis.  They have put the public’s health at risk by allowing inaccurate and potentially fraudulent tests to spread unchecked.”

 

The Subcommittee’s key preliminary findings include:

 

  • White House plans to reopen economy are flawed by their dependence on coronavirus antibody tests, which face unanswered scientific questions of utility and accuracy.
     
  • FDA did not review any coronavirus “rapid” antibody test kits before they went on the market, and a lack of enforcement by FDA has allowed manufacturers to make fraudulent claims about their efficacy.
     
  • FDA is unable to validate the accuracy of antibody tests that are already on the market, and companies are ignoring requests from HHS to voluntarily submit their tests for validation.
     
  • FDA and CDC have not put forth standards and guidelines for serological antibody tests, departing from practices governing molecular tests.
     
  • FDA has failed to police the coronavirus serological antibody test market, has taken no public enforcement action against any company, and has not conveyed any clear policy on serological tests, but rather has issued a series of unclear “clarifications.”

 

Chairman Krishnamoorthi expanded the investigation into unapproved, in-home, coronavirus test kits by sending letters to three additional companies—Vault Health, RUCDR Infinite Biologics, and ARCpoint Labs—that may be violating FDA’s policy.  ARCpoint Labs appears to be spreading dangerous advice to “discontinue social distancing.”

 

Click here to read the memo.

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Issues: 
116th Congress